As was the case with DePuy hip replacements, the U.S. Food and Drug Administration (FDA) may order that a medical device manufacturer either temporarily or permanently remove its product from the market.
Oftentimes, when a product is taken off the market for a short period of time, it's done so in order to inspect it for any potential defects, to make adjustments to it or repair flaws that have been discovered. If new dangers associated with using the device are discovered after it's released to market, then it also may be recalled so that a warning label can be affixed to it.
A medical device may be recalled for a lengthier period of time if the FDA has reason to believe that the medical device may be dangerous enough that those already placed with it need to be contacted to advise them of such. Additionally, it may be recalled for an extended period of time if the FDA believes that those already equipped with it need to be subjected to more extensive monitoring than has already been done by its manufacturer.
Medical devices may be permanently recalled if adjustments or repairs cannot be completed as anticipated or if it's shown to have an adverse impact on patients' health. If the device is believed to be particularly dangerous, then the FDA may even order that the manufacturer destroy it.
The FDA classifies recalls into one of three categories to give the public a better understanding of just how dangerous it is. Medical devices that are believed to pose the highest risk of injury or death are placed into Class I.
Those that are believed to have some degree of probability of resulting in serious health complications for a patient or kill them are classified as Class II recalls. Medical devices with the lowest likelihood of putting a patient at risk for injury or health problems are classified as Class III recalls.
If you've had your health adversely affected by either a DePuy hip replacement or any other defective medical device, then a Nashville products liability attorney can provide guidance in your legal case.